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Peptide Receptor Radionuclide Therapy Administered to Participants With Meningioma With 67Cu-SARTATE™

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936426
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Clarity Pharmaceuticals Ltd

Brief Summary:
The primary purpose of this study is to investigate the safety and tolerability of a single dose of Cu-64 SARTATE and multiple doses of Cu-67 SARTATE administered to participants with meningioma. All participants in this study will be injected with a single dose of Cu-64 SARTATE to demonstrate how it is absorbed in the body. Then participants will receive individualised doses of Cu-67 SARTATE for up to 4 cycles.

Condition or disease Intervention/treatment Phase
Meningioma Drug: Cu-64 SARTATE and Cu-67 SARTATE Phase 1 Phase 2

Detailed Description:
This is a single centre, open label, non-randomised, single cohort, multiple dose study of Cu-67 SARTATE administered to male and female participants diagnosed with grade I, II, or III meningioma. The maximum allowable dose will be calculated using dosimetry data acquired from PET/CT scans completed during a pre-treatment diagnostic & dosimetry phase using Cu-64 SARTATE, a structurally identical molecule radiolabelled with copper-64 (Cu-64), instead of copper-67 (Cu-67). Approximately 6 participants will be enrolled in the study. Participants will have up to 4 therapy cycles (6-12 weeks apart). Safety visits will occur between each cycle at bi-weekly intervals to ensure the participant meets the safety criteria prior to their next therapy. An efficacy assessment will be conducted following cycle 2 to determine if a subsequent 2 cycles of therapy will be administered. Participants who complete all four cycles of Cu-67 SARTATE therapy, will complete their final study visit at 12 weeks post administration of cycle 4.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peptide Receptor Radionuclide Therapy Administered to Participants With Meningioma With 67Cu-SARTATE™: A Single-centre, Open-label, Non- Randomised, Phase I-IIa Theranostic Clinical Trial
Actual Study Start Date : July 9, 2018
Actual Primary Completion Date : September 19, 2019
Actual Study Completion Date : September 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SARTATE
All participants will receive 200 MBq of Cu-64 SARTATE given as a single bolus intravenous injection at Day 0. Participants will receive up to four administrations of Cu-67 SARTATE via a slow intravenous infusion over 30 minutes, 6 to 12 weeks apart. Individual activity administered per cycle will not exceed 5.1 GBq.
Drug: Cu-64 SARTATE and Cu-67 SARTATE
Cu-64 SARTATE diagnostic drug Cu-67 SARTATE therapy drug
Other Names:
  • SARTATE
  • copper SARTATE
  • Cu‐SARTATE
  • 64Cu-SARTATE
  • 67Cu-SARTATE
  • Cu-64 SARTATE
  • Cu-67 SARTATE
  • 64/67Cu-SARTATE
  • Cu-64/67 SARTATE




Primary Outcome Measures :
  1. Safety and tolerability of multiple doses of Cu-67 SARTATE using CTCAE version 4.03 [ Time Frame: 55 weeks ]
    Safety will be assessed via vital signs, laboratory tests, physical examinations, ECGs and spontaneous adverse event reporting.

  2. Safety and tolerability of a single dose of Cu-64 SARTATE using CTCAE version 4.03 [ Time Frame: 56 weeks ]
    Safety will be assessed via vital signs, laboratory tests, physical examinations, ECGs and spontaneous adverse event reporting.


Secondary Outcome Measures :
  1. Absorbed dose of Cu-64 SARTATE in target, non-target organs and whole body. [ Time Frame: 1, 4 and 24 hours post administration of Cu-64 SARTATE. ]
    Absorbed doses (mSv/MBq) will be calculated using PET/CT scans acquired at 1, 4 and 24 hours post administration of Cu-64 SARTATE.

  2. Absorbed dose of Cu-67 SARTATE in target, non-target organs and whole body. [ Time Frame: 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE. ]
    Absorbed doses (mSv/MBq) will be calculated using SPECT/CT scans acquired at 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.

  3. Maximum and mean SUV of Cu-64 SARTATE in target organs and SSTR binding lesions. [ Time Frame: 1, 4 and 24 hours post administration of Cu-64 SARTATE. ]
    Maximum and mean SUV will be calculated using PET/CT scans acquired at 1, 4 and 24 hours post administration of Cu-64 SARTATE.

  4. Maximum and mean SUV of Cu-67 SARTATE in target organs and SSTR binding lesions. [ Time Frame: 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE. ]
    Maximum and mean SUV will be calculated using SPECT/CT scans acquired at 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.

  5. Activity of Cu-64 SARTATE in target and non-target organs and SSTR binding lesions as a percentage of the administered dose. [ Time Frame: 1, 4 and 24 hours post administration of Cu-64 SARTATE. ]
    The percentage of the administered dose will be calculated using PET/CT scans acquired at 1, 4 and 24 hours post administration of Cu-64 SARTATE.

  6. Activity of Cu-67 SARTATE in target and non-target organs and SSTR binding lesions as a percentage of the administered dose. [ Time Frame: 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE. ]
    The percentage of the administered dose will be calculated using SPECT/CT scans acquired at 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.

  7. Objective Response [ Time Frame: At 6 weeks post second administration of Cu-67 SARTATE, as well as at 6 and 12 weeks following the fourth administration. ]
    Objective response to therapy will be assessed according to the RANO Response Criteria for Meningioma, as measured by MRI and clinical status.

  8. Qualitative analysis of PET/CT scans post administration of Cu-64 SARTATE. [ Time Frame: 1, 4 and 24 hours post administration of Cu-64 SARTATE. ]
    Qualitative analysis of PET/CT scans to identify uptake patterns.

  9. Qualitative analysis of SPECT/CT scans post administration of Cu-67 SARTATE. [ Time Frame: 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE. ]
    Qualitative analysis of SPECT/CT scans to identify uptake patterns.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent.
  2. Age greater than or equal to 50 years.
  3. Life expectancy greater than or equal to 3 months.
  4. Has adequate organ function as defined by the following laboratory values obtained within 28 days prior to administration of Cu-64 SARTATE:

    1. Estimated glomerular filtration rate (eGFR) greater than 40ml/min as measured using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
    2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3.0 x upper limit of normal (ULN).
    3. QT interval less than /=450msec as measured by 12 lead ECG.
  5. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
  6. Diagnosis of recurrent or progressive histologically confirmed WHO grade I-III meningioma which has failed standard of care therapies. Patients will be considered to have failed standard care when they have disease that is progressing despite standard treatment (primarily radiotherapy) or where, in the opinion of their treating physician, further standard therapy is considered to be of sufficiently high risk of complication as to warrant consideration of alternate therapies.
  7. Male participants must agree to use contraception methods from Day 0 through to 4 weeks after the last dose of Cu-67 SARTATE.
  8. A female participant is eligible to participate if she is of:

    1. Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and oestradiol less than 40 pg/ml (less than 140 pmol/l) is confirmatory].
    2. Child-bearing potential and agrees to use contraception methods for an appropriate period of time (as determined by the Investigator) prior to Day 0 to sufficiently minimize the risk of pregnant females being enrolled. These measures are the combination of a barrier method AND established (greater than 2 cycles) hormonal methods (e.g. the oral contraceptive pill). Absolute sexual abstinence may be considered acceptable at the discretion of the investigator. Abstinence for the 12 days prior to therapy to allow for serum B-hCG assessment which should then ensure the patient is not pregnant prior to therapy administration.
    3. Female participants must agree to use contraception until four weeks after the last dose of Cu-67 SARTATE.

Exclusion Criteria:

  1. Known sensitivity or allergy to somatostatin analogues.
  2. Participants who have received interventional treatment for their meningioma within the four weeks prior to Day 0.
  3. Any major surgery within the four weeks prior to Day 0.
  4. Any additional planned interventions, including surgery or radiation therapy that would interfere with safety or efficacy assessments.
  5. Treatment with long acting somatostatin analogues within 28 days prior to Day 0. Treatment with short acting somatostatin analogues within 24 hours prior to Day 0.
  6. Any other malignancy in the past 5 years except for cervical intraepithelial neoplasia (CIN) of the cervix, squamous cell carcinoma (SCC) of the skin, basal cell carcinoma (BCC) of the skin or clinical insignificant prostate cancer not requiring prior therapy.
  7. Breastfeeding females and pregnant females.
  8. Treatment with any investigational agent received within four weeks prior to Day 0.
  9. Participants unwilling or unable to comply with protocol requirements.
  10. Urinary or faecal incontinence of sufficient degree to be of concern for contamination risk in the opinion of the Investigator.
  11. Peptide receptor radionuclide therapy (PRRT) at any time prior to enrolment in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936426


Locations
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Australia, New South Wales
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Sponsors and Collaborators
Clarity Pharmaceuticals Ltd
Investigators
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Principal Investigator: Geoffrey Schembri, MD Royal North Shore Hospital
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Responsible Party: Clarity Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT03936426    
Other Study ID Numbers: CL02
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meningioma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Copper
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs